0.1.0 - ci-build

RuSEMD, published by HL7 FHIR Россия. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/fhir-ru/Ru-SEMD/ and changes regularly. See the Directory of published versions

Resource Profile: PLI_SEMD_Device - Detailed Descriptions

Active as of 2025-07-15

Definitions for the pli-semd-device resource profile.

Guidance on how to interpret the contents of this table can be foundhere

0. Device
Definition

A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.

ShortItem used in healthcare
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdev-1: only one Device.name.display SHALL be true when there is more than one Device.name (name.where(display=true).count() <= 1)
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. Device.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Device.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
6. Device.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. Device.identifier
Definition

Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

ShortInstance identifier
Comments

Certain attributes, like serial number and UDI Carrier (the HRF or AIDC barcode string) are not device instance identifiers as they are not consistently able to uniquely identify the instance of a device, thus are not appropriate to be used to value Device.identifier. The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. The identifier is typically valued if the serialNumber or lotNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control10..*
TypeIdentifier
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Device.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ system
  • 10. Device.identifier:analyserId
    Slice NameanalyserId
    Definition

    Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

    ShortИдентификатор анализатораInstance identifier
    Comments

    Certain attributes, like serial number and UDI Carrier (the HRF or AIDC barcode string) are not device instance identifiers as they are not consistently able to uniquely identify the instance of a device, thus are not appropriate to be used to value Device.identifier. The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. The identifier is typically valued if the serialNumber or lotNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.

    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control10..1*
    TypeIdentifier
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    12. Device.identifier:analyserId.use
    Definition

    The purpose of this identifier.

    Shortusual | official | temp | secondary | old (If known)
    Comments

    Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

    Control0..1
    BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
    (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

    Identifies the purpose for this identifier, if known .

    Typecode
    Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    14. Device.identifier:analyserId.type
    Definition

    A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

    ShortDescription of identifier
    Comments

    This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

    Control10..1
    BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type
    (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

    A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

    TypeCodeableConcept
    Is Modifierfalse
    Summarytrue
    Requirements

    Allows users to make use of identifiers when the identifier system is not known.

    Pattern Value{
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
        "code" : "SNO"
      }]
    }
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    16. Device.identifier:analyserId.system
    Definition

    Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

    ShortThe namespace for the identifier value
    Comments

    Identifier.system is always case sensitive.

    Control10..1
    Typeuri
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

    Pattern Valuehttps://fhir.ru/ig/semd/systems/analyser
    Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. Device.status
    Definition

    The Device record status. This is not the status of the device like availability.

    Shortactive | inactive | entered-in-error
    Control0..1
    BindingThe codes SHALL be taken from FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|5.0.0
    (required to http://hl7.org/fhir/ValueSet/device-status|5.0.0)

    The record status of the device.

    Typecode
    Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

    Guidance on how to interpret the contents of this table can be foundhere

    0. Device
    2. Device.identifier
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control1..?
    SlicingThis element introduces a set of slices on Device.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ system
    • 4. Device.identifier:analyserId
      Slice NameanalyserId
      ShortИдентификатор анализатора
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control1..1
      6. Device.identifier:analyserId.type
      Control1..?
      Pattern Value{
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
          "code" : "SNO"
        }]
      }
      8. Device.identifier:analyserId.system
      Control1..?
      Pattern Valuehttps://fhir.ru/ig/semd/systems/analyser

      Guidance on how to interpret the contents of this table can be foundhere

      0. Device
      Definition

      A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.

      ShortItem used in healthcare
      Control0..*
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsdev-1: only one Device.name.display SHALL be true when there is more than one Device.name (name.where(display=true).count() <= 1)
      dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
      dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
      dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
      dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
      dom-6: A resource should have narrative for robust management (text.`div`.exists())
      2. Device.id
      Definition

      The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

      ShortLogical id of this artifact
      Comments

      Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

      Control0..1
      Typeid
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      4. Device.meta
      Definition

      The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

      ShortMetadata about the resource
      Control0..1
      TypeMeta
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      6. Device.implicitRules
      Definition

      A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

      ShortA set of rules under which this content was created
      Comments

      Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

      Control0..1
      Typeuri
      Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      8. Device.language
      Definition

      The base language in which the resource is written.

      ShortLanguage of the resource content
      Comments

      Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

      Control0..1
      BindingThe codes SHALL be taken from AllLanguages
      (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

      IETF language tag for a human language

      Typecode
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      10. Device.text
      Definition

      A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

      ShortText summary of the resource, for human interpretation
      Comments

      Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

      Control0..1
      This element is affected by the following invariants: dom-6
      TypeNarrative
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Alternate Namesnarrative, html, xhtml, display
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      12. Device.contained
      Definition

      These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

      ShortContained, inline Resources
      Comments

      This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

      Control0..*
      This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
      TypeResource
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Alternate Namesinline resources, anonymous resources, contained resources
      14. Device.extension
      Definition

      May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

      ShortAdditional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      16. Device.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

      ShortExtensions that cannot be ignored
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
      Must Supportfalse
      Summarytrue
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      18. Device.identifier
      Definition

      Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

      ShortInstance identifier
      Comments

      Certain attributes, like serial number and UDI Carrier (the HRF or AIDC barcode string) are not device instance identifiers as they are not consistently able to uniquely identify the instance of a device, thus are not appropriate to be used to value Device.identifier. The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. The identifier is typically valued if the serialNumber or lotNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.

      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control1..*
      TypeIdentifier
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      SlicingThis element introduces a set of slices on Device.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ system
      • 20. Device.identifier:analyserId
        Slice NameanalyserId
        Definition

        Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

        ShortИдентификатор анализатора
        Comments

        Certain attributes, like serial number and UDI Carrier (the HRF or AIDC barcode string) are not device instance identifiers as they are not consistently able to uniquely identify the instance of a device, thus are not appropriate to be used to value Device.identifier. The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. The identifier is typically valued if the serialNumber or lotNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.

        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control1..1
        TypeIdentifier
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        22. Device.identifier:analyserId.id
        Definition

        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

        ShortUnique id for inter-element referencing
        Control0..1
        This element is affected by the following invariants: ele-1
        Typeid
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        24. Device.identifier:analyserId.extension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

        ShortAdditional content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on Device.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 26. Device.identifier:analyserId.use
          Definition

          The purpose of this identifier.

          Shortusual | official | temp | secondary | old (If known)
          Comments

          Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

          Control0..1
          BindingThe codes SHALL be taken from IdentifierUse
          (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

          Identifies the purpose for this identifier, if known .

          Typecode
          Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          28. Device.identifier:analyserId.type
          Definition

          A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

          ShortDescription of identifier
          Comments

          This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

          Control1..1
          BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
          (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

          A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

          TypeCodeableConcept
          Is Modifierfalse
          Summarytrue
          Requirements

          Allows users to make use of identifiers when the identifier system is not known.

          Pattern Value{
            "coding" : [{
              "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
              "code" : "SNO"
            }]
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          30. Device.identifier:analyserId.system
          Definition

          Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

          ShortThe namespace for the identifier value
          Comments

          Identifier.system is always case sensitive.

          Control1..1
          Typeuri
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

          Pattern Valuehttps://fhir.ru/ig/semd/systems/analyser
          Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          32. Device.identifier:analyserId.value
          Definition

          The portion of the identifier typically relevant to the user and which is unique within the context of the system.

          ShortThe value that is unique
          Comments

          If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

          Control0..1
          This element is affected by the following invariants: ident-1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Example<br/><b>General</b>:123456
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          34. Device.identifier:analyserId.period
          Definition

          Time period during which identifier is/was valid for use.

          ShortTime period when id is/was valid for use
          Control0..1
          TypePeriod
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          36. Device.identifier:analyserId.assigner
          Definition

          Organization that issued/manages the identifier.

          ShortOrganization that issued id (may be just text)
          Comments

          The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

          Control0..1
          TypeReference(Organization)
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          38. Device.displayName
          Definition

          The name used to display by default when the device is referenced. Based on intent of use by the resource creator, this may reflect one of the names in Device.name, or may be another simple name.

          ShortThe name used to display by default when the device is referenced
          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          40. Device.definition
          Definition

          The reference to the definition for the device.

          ShortThe reference to the definition for the device
          Control0..1
          TypeCodeableReference(DeviceDefinition)
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          42. Device.udiCarrier
          Definition

          Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

          ShortUnique Device Identifier (UDI) Barcode string
          Comments

          UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          44. Device.udiCarrier.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          This element is affected by the following invariants: ele-1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          46. Device.udiCarrier.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          48. Device.udiCarrier.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          Summarytrue
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content, modifiers
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          50. Device.udiCarrier.deviceIdentifier
          Definition

          The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.

          ShortMandatory fixed portion of UDI
          Control1..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Alternate NamesDI
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          52. Device.udiCarrier.issuer
          Definition

          Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include:

          1. GS1: http://hl7.org/fhir/NamingSystem/gs1-di,
          2. HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-diI,
          3. ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
          4. ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di # Informationsstelle für Arzneispezialitäten (IFA GmbH) (EU only): http://hl7.org/fhir/NamingSystem/ifa-gmbh-di.
          ShortUDI Issuing Organization
          Control1..1
          Typeuri
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Alternate NamesBarcode System
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          54. Device.udiCarrier.jurisdiction
          Definition

          The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/us-fda-udi or in the European Union by the European Commission http://hl7.org/fhir/NamingSystem/eu-ec-udi.

          ShortRegional UDI authority
          Control0..1
          Typeuri
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Requirements

          Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          56. Device.udiCarrier.carrierAIDC
          Definition

          The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.

          ShortUDI Machine Readable Barcode String
          Comments

          The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

          Control0..1
          Typebase64Binary
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Alternate NamesAutomatic Identification and Data Capture
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          58. Device.udiCarrier.carrierHRF
          Definition

          The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

          ShortUDI Human Readable Barcode String
          Comments

          If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Alternate NamesHuman Readable Form
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          60. Device.udiCarrier.entryType
          Definition

          A coded entry to indicate how the data was entered.

          Shortbarcode | rfid | manual | card | self-reported | electronic-transmission | unknown
          Control0..1
          BindingThe codes SHALL be taken from UDIEntryType
          (required to http://hl7.org/fhir/ValueSet/udi-entry-type|5.0.0)

          Codes to identify how UDI data was entered.

          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Requirements

          Supports a way to distinguish hand entered from machine read data.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          62. Device.status
          Definition

          The Device record status. This is not the status of the device like availability.

          Shortactive | inactive | entered-in-error
          Control0..1
          BindingThe codes SHALL be taken from FHIRDeviceStatus
          (required to http://hl7.org/fhir/ValueSet/device-status|5.0.0)

          The record status of the device.

          Typecode
          Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          64. Device.availabilityStatus
          Definition

          The availability of the device.

          Shortlost | damaged | destroyed | available
          Control0..1
          BindingUnless not suitable, these codes SHALL be taken from FHIRDeviceAvailabilityStatus
          (extensible to http://hl7.org/fhir/ValueSet/device-availability-status)

          The availability status reason of the device.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          66. Device.biologicalSourceEvent
          Definition

          An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled.

          ShortAn identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
          Comments

          Necessary to support mandatory requirements for traceability from donor/source to recipient and vice versa, while also satisfying donor anonymity requirements. The element is defined consistently across BiologicallyDerivedProduct, NutritionProduct, and Device. The identifier references an event that links to a single biological entity such as a blood donor, or to multiple biological entities (e.g. when the product is an embryo or a pooled platelet product). A single biologicalSourceEvent identifier may appear on multiple products of many types derived from a single donation event or source extraction. As an example, a single donation event may provide 2 kidneys and a liver for organ transplantation, 2 corneas for eye surgery, heart valves and arterial tissue for cardiovascular surgery, multiple skin grafts, tendons, multiple shaped bone grafts and a large number of bone putty/paste products; and each of them may be assigned to the same biological source event identifier.

          Control0..1
          TypeIdentifier
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Alternate NamesDistinct Identification Code (DIC)
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          68. Device.manufacturer
          Definition

          A name of the manufacturer or entity legally responsible for the device.

          ShortName of device manufacturer
          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          70. Device.manufactureDate
          Definition

          The date and time when the device was manufactured.

          ShortDate when the device was made
          Control0..1
          TypedateTime
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          72. Device.expirationDate
          Definition

          The date and time beyond which this device is no longer valid or should not be used (if applicable).

          ShortDate and time of expiry of this device (if applicable)
          Control0..1
          TypedateTime
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          74. Device.lotNumber
          Definition

          Lot number assigned by the manufacturer.

          ShortLot number of manufacture
          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          76. Device.serialNumber
          Definition

          The serial number assigned by the organization when the device was manufactured.

          ShortSerial number assigned by the manufacturer
          Comments

          Alphanumeric Maximum 20. While a serial number is a type of identifier, in the context of devices for which a UDI is required, thus a serial number may be part of the production identifier, it is more informative to have the serial number as a dedicated attribute together with the other UDI production identifier. When the device is not subject to including the UDI (e.g., its presence and exchange is not mandated by local regulatory requirements or specific use case at hand), thus the concept of production identifiers is not relevant as a set, it remains helpful for consistency to still use Device.serialNumber rather than using Device.identifier with an appropriate type. Systems that do not realize an identifier is a serial number may place it in Device.identifier or if the identifier.system is known for the serial number, it may also be populated in the Device.identifier as a globally unique id_.

          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          78. Device.name
          Definition

          This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.

          ShortThe name or names of the device as known to the manufacturer and/or patient
          Control0..*
          This element is affected by the following invariants: dev-1
          TypeBackboneElement
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          80. Device.name.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          This element is affected by the following invariants: ele-1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          82. Device.name.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          84. Device.name.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          Summarytrue
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content, modifiers
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          86. Device.name.value
          Definition

          The actual name that identifies the device.

          ShortThe term that names the device
          Control1..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Alternate NamesΣ
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          88. Device.name.type
          Definition

          Indicates the kind of name. RegisteredName | UserFriendlyName | PatientReportedName.

          Shortregistered-name | user-friendly-name | patient-reported-name
          Control1..1
          BindingThe codes SHALL be taken from DeviceNameType
          (required to http://hl7.org/fhir/ValueSet/device-nametype|5.0.0)

          The type of name the device is referred by.

          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          90. Device.name.display
          Definition

          Indicates the default or preferred name to be displayed.

          ShortThe preferred device name
          Control0..1
          This element is affected by the following invariants: dev-1
          Typeboolean
          Is Modifiertrue because This element is labelled as a modifier because it is a status element that can indicate that that a name is preferred.
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          92. Device.modelNumber
          Definition

          The manufacturer's model number for the device.

          ShortThe manufacturer's model number for the device
          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          94. Device.partNumber
          Definition

          The part number or catalog number of the device.

          ShortThe part number or catalog number of the device
          Comments

          Alphanumeric Maximum 20.

          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          96. Device.category
          Definition

          Devices may be associated with one or more categories.

          ShortIndicates a high-level grouping of the device
          Control0..*
          BindingFor example codes, see FHIRDeviceCategory
          (example to http://hl7.org/fhir/ValueSet/device-category)

          Categories of medical devices.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          98. Device.type
          Definition

          The kind or type of device. A device instance may have more than one type - in which case those are the types that apply to the specific instance of the device.

          ShortThe kind or type of device
          Comments

          Multiple device types are use when a device is categorized in more than one context – for example, hybrid devices in which the device is both of type gateway and sensor.

          Control0..*
          BindingFor example codes, see DeviceType
          (example to http://hl7.org/fhir/ValueSet/device-type)

          Codes to identify medical devices.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          100. Device.version
          Definition

          The actual design of the device or software version running on the device.

          ShortThe actual design of the device or software version running on the device
          NoteThis is a business version Id, not a resource version Id (see discussion)
          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          102. Device.version.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          This element is affected by the following invariants: ele-1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          104. Device.version.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          106. Device.version.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          Summarytrue
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content, modifiers
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          108. Device.version.type
          Definition

          The type of the device version, e.g. manufacturer, approved, internal.

          ShortThe type of the device version, e.g. manufacturer, approved, internal
          Control0..1
          BindingFor example codes, see DeviceVersionType
          (example to http://hl7.org/fhir/ValueSet/device-versiontype)

          The type of version indicated for the device.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Alternate NamesΣ
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          110. Device.version.component
          Definition

          The hardware or software module of the device to which the version applies.

          ShortThe hardware or software module of the device to which the version applies
          Comments

          Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.

          Control0..1
          TypeIdentifier
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          112. Device.version.installDate
          Definition

          The date the version was installed on the device.

          ShortThe date the version was installed on the device
          Control0..1
          TypedateTime
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          114. Device.version.value
          Definition

          The version text.

          ShortThe version text
          Control1..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          116. Device.conformsTo
          Definition

          Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards.

          ShortIdentifies the standards, specifications, or formal guidances for the capabilities supported by the device
          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          118. Device.conformsTo.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          This element is affected by the following invariants: ele-1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          120. Device.conformsTo.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          122. Device.conformsTo.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          Summarytrue
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content, modifiers
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          124. Device.conformsTo.category
          Definition

          Describes the type of the standard, specification, or formal guidance.

          ShortDescribes the common type of the standard, specification, or formal guidance. communication | performance | measurement
          Control0..1
          BindingFor example codes, see DeviceSpecificationCategory
          (example to http://hl7.org/fhir/ValueSet/device-specification-category)

          The kind of standards used by the device.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          126. Device.conformsTo.specification
          Definition

          Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres.

          ShortIdentifies the standard, specification, or formal guidance that the device adheres to
          Control1..1
          BindingFor example codes, see DeviceSpecificationType
          (example to http://hl7.org/fhir/ValueSet/device-specification-type)

          The type of version indicated for the device.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          128. Device.conformsTo.version
          Definition

          Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other label.

          ShortSpecific form or variant of the standard
          NoteThis is a business version Id, not a resource version Id (see discussion)
          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          130. Device.property
          Definition

          Static or essentially fixed characteristics or features of the device (e.g., time or timing attributes, resolution, accuracy, intended use or instructions for use, and physical attributes) that are not otherwise captured in more specific attributes.

          ShortInherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
          Comments

          Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific [DeviceMetric] and recorded using [Observation]. Static characteristics of a device could also be documented in an associated [DeviceDefinition] instance. The Device instance's properties, and their values, could be, but need not be, the same as those described in an associated DeviceDefinition.

          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          132. Device.property.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          This element is affected by the following invariants: ele-1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          134. Device.property.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          136. Device.property.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          Summarytrue
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content, modifiers
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          138. Device.property.type
          Definition

          Code that specifies the property, such as resolution, color, size, being represented.

          ShortCode that specifies the property being represented
          Control1..1
          BindingFor example codes, see DeviceType
          (example to http://hl7.org/fhir/ValueSet/device-property-type)

          Device property type.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          140. Device.property.value[x]
          Definition

          The value of the property specified by the associated property.type code.

          ShortValue of the property
          Comments

          The text element in CodeableConcept.text is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g. a custom implant size, or a security classification which depends on configuration). Otherwise the string choice type is used for descriptive properties, or instructions.

          Control1..1
          TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Attachment
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          142. Device.mode
          Definition

          The designated condition for performing a task with the device.

          ShortThe designated condition for performing a task
          Control0..1
          BindingFor example codes, see FHIRDeviceOperationMode
          (example to http://hl7.org/fhir/ValueSet/device-operation-mode)

          Operational mode of a device.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          144. Device.cycle
          Definition

          The series of occurrences that repeats during the operation of the device.

          ShortThe series of occurrences that repeats during the operation of the device
          Control0..1
          TypeCount
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          146. Device.duration
          Definition

          A measurement of time during the device's operation (e.g., days, hours, mins, etc.).

          ShortA measurement of time during the device's operation (e.g., days, hours, mins, etc.)
          Control0..1
          TypeDuration
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          148. Device.owner
          Definition

          An organization that is responsible for the provision and ongoing maintenance of the device.

          ShortOrganization responsible for device
          Control0..1
          TypeReference(Organization)
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          150. Device.contact
          Definition

          Contact details for an organization or a particular human that is responsible for the device.

          ShortDetails for human/organization for support
          Comments

          used for troubleshooting etc.

          Control0..*
          TypeContactPoint
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          152. Device.location
          Definition

          The place where the device can be found.

          ShortWhere the device is found
          Control0..1
          TypeReference(Location)
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Requirements

          Device.location can be used to track device location.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          154. Device.url
          Definition

          A network address on which the device may be contacted directly.

          ShortNetwork address to contact device
          Comments

          If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

          Control0..1
          Typeuri
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          156. Device.endpoint
          Definition

          Technical endpoints providing access to services provided by the device defined at this resource.

          ShortTechnical endpoints providing access to electronic services provided by the device
          Control0..*
          TypeReference(Endpoint)
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          158. Device.gateway
          Definition

          The linked device acting as a communication controller, data collector, translator, or concentrator for the current device (e.g., mobile phone application that relays a blood pressure device's data).

          ShortLinked device acting as a communication/data collector, translator or controller
          Comments

          The Device.gateway may be used when the Device being referenced has a gateway and/or to capture one or more gateways associated with the device. If the Gateway is included in the Observation resource, the Observation.gatewayDevice should be used instead.

          Control0..*
          TypeCodeableReference(Device)
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          160. Device.note
          Definition

          Descriptive information, usage information or implantation information that is not captured in an existing element.

          ShortDevice notes and comments
          Control0..*
          TypeAnnotation
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          162. Device.safety
          Definition

          Provides additional safety characteristics about a medical device. For example devices containing latex.

          ShortSafety Characteristics of Device
          Control0..*
          BindingFor example codes, see DeviceSafety
          (example to http://hl7.org/fhir/ValueSet/device-safety)
          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          164. Device.parent
          Definition

          The higher level or encompassing device that this device is a logical part of.

          ShortThe higher level or encompassing device that this device is a logical part of
          Comments

          For example a vital signs monitor (parent) where three separate modules can be plugged into such as interchangeable blood pressure, oximeter, temperature modules. These modules are represented as devices with the .parent valued to the vital signs monitor when plugged in.

          Control0..1
          TypeReference(Device)
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))